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    Clinical Trial Results:
    Persistence of Anti-HBs Antibodies at 6 to 7 Years of Age in Subjects Having Received a DTaP-IPV-HB-PRP~T Hexavalent Vaccine at 3, 5, and 11 to 12 Months of Age, and Evaluation of Their Immune Memory Following a Challenge Vaccination with a Standalone Hepatitis B Vaccine

    Summary
    EudraCT number
    		 2017-004069-29
    Trial protocol
    		 FI  
    Global end of trial date
    20 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2020
    First version publication date
    04 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A3L00052
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1183-6489
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur
    Sponsor organisation address
    14 Espace Henry Vallée, Lyon, France, 69007
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To describe the persistence of anti-hepatitis B surface (HBs) antibodies at 6 to 7 years of age in subjects having received an hexavalent vaccine at 3, 5 and 11 to 12 months of age according to the vaccine received during Study A3L38 (Hexyon [Group 1] or Infanrix hexa [Group 2]). 2) To evaluate the immune response against HBs antigen one month after a vaccination with a standalone monovalent HB vaccine (challenge dose).
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Feb 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 225
    Worldwide total number of subjects
    225
    EEA total number of subjects
    225
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    225
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at 10 sites in Finland from 13 February 2019 to 20 June 2019.

    Pre-assignment
    Screening details
    		 All subjects who were previously vaccinated in study A3L38 (2012-001054-26) (3 doses of either DTaP-IPV-HB-PRP~T hexavalent combined vaccine [Hexyon® {Group 1}] or DTaP-IPV-HB/Hib combined vaccine [Infanrix® hexa {Group 2}]) were enrolled in this study A3L00052.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Hexyon®/Engerix® B
    Arm description
    		 Subjects who were vaccinated in the prior study A3L38 with 3 doses of DTaP-IPV-HB-PRP~T hexavalent combined vaccine (Hexyon® vaccine) received a single dose (challenge dose) of Engerix® B (purified monovalent HBs antigen) vaccine on Day 0, in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix® B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 millilitre (mL), intramuscular, 1 injection on Day 0.

    Arm title
    		 Group 2: Infanrix® hexa/Engerix® B
    Arm description
    		 Subjects who were vaccinated in the prior study A3L38 with 3 doses of DTaP-IPV-HB/Hib combined vaccine (Infanrix® hexa) received a single dose (challenge dose) of Engerix® B (purified monovalent HBs antigen) vaccine on Day 0, in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix® B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0.

    Number of subjects in period 1
    		Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Started
    111
    114
    Completed
    108
    113
    Not completed
    3
    1
         Protocol deviation
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Hexyon®/Engerix® B
    Reporting group description
    		 Subjects who were vaccinated in the prior study A3L38 with 3 doses of DTaP-IPV-HB-PRP~T hexavalent combined vaccine (Hexyon® vaccine) received a single dose (challenge dose) of Engerix® B (purified monovalent HBs antigen) vaccine on Day 0, in this study.

    Reporting group title
    Group 2: Infanrix® hexa/Engerix® B
    Reporting group description
    		 Subjects who were vaccinated in the prior study A3L38 with 3 doses of DTaP-IPV-HB/Hib combined vaccine (Infanrix® hexa) received a single dose (challenge dose) of Engerix® B (purified monovalent HBs antigen) vaccine on Day 0, in this study.

    Reporting group values
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B Total
    Number of subjects
    		 111 114 225
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.00 ± 0 6.00 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    		 52 58 110
        Male
    		 59 56 115

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Hexyon®/Engerix® B
    Reporting group description
    		 Subjects who were vaccinated in the prior study A3L38 with 3 doses of DTaP-IPV-HB-PRP~T hexavalent combined vaccine (Hexyon® vaccine) received a single dose (challenge dose) of Engerix® B (purified monovalent HBs antigen) vaccine on Day 0, in this study.

    Reporting group title
    Group 2: Infanrix® hexa/Engerix® B
    Reporting group description
    		 Subjects who were vaccinated in the prior study A3L38 with 3 doses of DTaP-IPV-HB/Hib combined vaccine (Infanrix® hexa) received a single dose (challenge dose) of Engerix® B (purified monovalent HBs antigen) vaccine on Day 0, in this study.

    Primary: Geometric Mean Concentrations (GMCs) of Anti-HBs Antibody at Day 0

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Anti-HBs Antibody at Day 0 [1]
    End point description
    GMCs of anti-HBs antibodies was measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System assay using chemiluminescence detection technology. The analysis was performed on the per-protocol analysis set (PPAS) population which included subjects who received the challenge dose and had no protocol deviation.
    End point type
    Primary
    End point timeframe
    At Baseline (Day 0)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Number of subjects analysed
    91
    98
    Units: Titers (1/dilution)
        geometric mean (confidence interval 95%)
    15.8 (10.9 to 22.8)
    38.5 (26.8 to 55.2)
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to (>=) 10 Milli-International Units per Litre (mIU/mL) at Day 0

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    End point title
    		 Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to (>=) 10 Milli-International Units per Litre (mIU/mL) at Day 0 [2]
    End point description
    Anti-HBs antibodies concentration >= 10 mIU/mL was measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System assay using chemiluminescence detection technology. The analysis was performed on the PPAS population.
    End point type
    Primary
    End point timeframe
    At Baseline (Day 0)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Number of subjects analysed
    91
    98
    Units: subjects
        number (confidence interval 95%)
    49 (43.1 to 64.4)
    72 (63.6 to 81.9)
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti-HBs Antibody Concentration >=100 mIU/mL at Day 0

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    End point title
    		 Number of Subjects With Anti-HBs Antibody Concentration >=100 mIU/mL at Day 0 [3]
    End point description
    Anti-HBs antibodies concentration >=100 mIU/mL was measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System assay using chemiluminescence detection technology. The analysis was performed on the PPAS population.
    End point type
    Primary
    End point timeframe
    At Baseline (Day 0)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Number of subjects analysed
    91
    98
    Units: subjects
        number (confidence interval 95%)
    17 (11.3 to 28.2)
    36 (27.2 to 47.1)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Anti-HBs Antibody at Day 28

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    End point title
    		 Geometric Mean Concentrations of Anti-HBs Antibody at Day 28 [4]
    End point description
    GMCs of anti-HBs antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System assay using chemiluminescence detection technology. The analysis was performed on the PPAS population.
    End point type
    Primary
    End point timeframe
    Post vaccination (Day 28)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Number of subjects analysed
    91
    98
    Units: Titers (1/dilution)
        geometric mean (confidence interval 95%)
    1816 (1100 to 2998)
    7036 (4591 to 10783)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Anti-HBs Antibody Concentration >=10 mIU/mL at Day 28

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    End point title
    		 Percentage of Subjects With Anti-HBs Antibody Concentration >=10 mIU/mL at Day 28 [5]
    End point description
    Anti-HBs antibodies concentration >=10 mIU/mL was measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System assay using chemiluminescence detection technology. The analysis was performed on the PPAS population.
    End point type
    Primary
    End point timeframe
    Post vaccination (Day 28)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Number of subjects analysed
    91
    98
    Units: percentage of subjects
        number (confidence interval 95%)
    96.7 (90.7 to 99.3)
    99.0 (94.4 to 100)
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti-HBs Antibody Concentration >=100 mIU/mL at Day 28

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    End point title
    		 Number of Subjects With Anti-HBs Antibody Concentration >=100 mIU/mL at Day 28 [6]
    End point description
    Anti-HBs antibodies concentration >=100 mIU/mL was measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System assay using chemiluminescence detection technology. The analysis was performed on the PPAS population.
    End point type
    Primary
    End point timeframe
    Post vaccination (Day 28)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Number of subjects analysed
    91
    98
    Units: subjects
        number (confidence interval 95%)
    79 (78.1 to 93.0)
    94 (89.9 to 98.9)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentration Ratio (GMCR) of Anti-HBs Antibody Concentrations

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    End point title
    		 Geometric Mean Concentration Ratio (GMCR) of Anti-HBs Antibody Concentrations [7]
    End point description
    GMCs of anti-HBs antibodies at Day 0 and Day 28 were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System assay using chemiluminescence detection technology. GMCRs were calculated as the ratio of GMTs at post-vaccination (Day 28)/baseline (Day 0). The analysis was performed on the PPAS population.
    End point type
    Primary
    End point timeframe
    At Baseline (Day 0) and Day 28
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Number of subjects analysed
    91
    98
    Units: ratio
        geometric mean (confidence interval 95%)
    90.1 (63.8 to 127)
    163 (126 to 211)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Anamnestic Response to the Challenge Dose for Anti-HBs Antibodies

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    End point title
    		 Percentage of Subjects With Anamnestic Response to the Challenge Dose for Anti-HBs Antibodies [8]
    End point description
    Anamnestic response was defined as anti-HBs antibody concentrations >=4-fold increase from pre-challenge dose (Day 0) to post-challenge dose (Day 28) in subjects seroprotected (>=10 mIU/mL) prior to challenge dose or anti-HB antibody concentrations >=10 mIU/mL post-challenge dose in subjects not seroprotected prior to challenge dose (greater than [<] 10 mIU/mL). Analysis was performed on PPAS population.
    End point type
    Primary
    End point timeframe
    Post vaccination (Day 28)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Number of subjects analysed
    91
    98
    Units: percentage of subjects
        number (confidence interval 95%)
    96.7 (90.7 to 99.3)
    99.0 (94.4 to 100)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Serious Adverse Events (SAEs)
    End point description
    An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event. Analysis was performed on full analysis set (FAS) population which included subjects who received the challenge dose.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Day 28
    End point values
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Number of subjects analysed
    108
    113
    Units: subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    SAEs were collected throughout the study (from Day 0 through Day 28 after vaccination).
    Adverse event reporting additional description
    Analysis was performed on FAS population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Group 1: Hexyon®/Engerix® B
    Reporting group description
    		 Subjects who were vaccinated in the prior study A3L38 with 3 doses of DTaP-IPV-HB-PRP~T hexavalent combined vaccine (Hexyon® vaccine) received a single dose (challenge dose) of Engerix® B (purified monovalent HBs antigen) vaccine on Day 0, in this study.

    Reporting group title
    Group 2: Infanrix® hexa/Engerix® B
    Reporting group description
    		 Subjects who were vaccinated in the prior study A3L38 with 3 doses of DTaP-IPV-HB/Hib combined vaccine (Infanrix® hexa) received a single dose (challenge dose) of Engerix® B (purified monovalent HBs antigen) vaccine on Day 0, in this study.

    Serious adverse events
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 113 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: Hexyon®/Engerix® B Group 2: Infanrix® hexa/Engerix® B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 113 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Non-serious adverse events were not collected in this study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2018
    Following changes were made: • The statement on the subject’s parent consent for future use was deleted. • A statement on the destruction of blood samples was added.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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